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Congenital Hyperinsulinism clinical trials

View clinical trials related to Congenital Hyperinsulinism.

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NCT ID: NCT06208215 Recruiting - Clinical trials for Congenital Hyperinsulinism

RZ358 Treatment for Congenital Hyperinsulinism

sunRIZE
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.

NCT ID: NCT05687474 Recruiting - Cystic Fibrosis Clinical Trials

Baby Detect : Genomic Newborn Screening

Start date: September 1, 2022
Phase:
Study type: Observational

Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions. With a simple blood test, rare genetic conditions can be easily detected, and the early start of transformative treatment will help avoid severe disabilities and increase the quality of life. Baby Detect Project is an innovative NBS program using a panel of target sequencing that aims to identify 126 treatable severe early onset genetic diseases at birth caused by 361 genes. The list of diseases has been established in close collaboration with the Paediatricians of the University Hospital in Liege. The investigators use dedicated dried blood spots collected between the first day and 28 days of life of babies, after a consent sign by parents.

NCT ID: NCT05597475 Recruiting - Obesity Clinical Trials

GLP1R-imaging in Post-RYGB Hypoglycemia

Start date: November 1, 2016
Phase: N/A
Study type: Interventional

In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between these patient groups. These highly relevant data will provide investigators with more information on the possible role of beta cell mass in the mechanisms of hyperinsulinemic hypoglycemia bariatric surgery.

NCT ID: NCT04732416 Recruiting - Clinical trials for Congenital Hyperinsulinism

HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)

Start date: October 28, 2021
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC). HM15136 will be administered once weekly in multiple doses to subjects in multiple age including pediatric to find appropriate exposure-response data.

NCT ID: NCT04720859 Recruiting - Clinical trials for Postprandial Hypoglycemia

Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)

CANA-PHH-RYGB
Start date: January 5, 2018
Phase: N/A
Study type: Interventional

Roux-en-Y gastric bypass (RYGB) is the most common surgical procedure for morbid obesity. However, it can present serious late complications, like postprandial hyperinsulinemic hypoglycemia (PHH). Recent data suggested an increase in intestinal SGLT1 after RYGB. However, there are no data on the inhibition of SLGT1 to prevent PHH in patients with prior RYBG. Objectives: To evaluate in patients that present PHH after RYGB: a) the effect of canagliflozin 300mg on the response to 100g glucose overload (OGTT); b) the pancreatic response after intra-arterial calcium stimulation. Material and methods: Prospective pilot study, including patients with PHH after RYGB, matched by age and gender with healthy controls. Basal OGTT and after 2-weeks of daily 300mg of canagliflozin will be performed. In addition, venous sampling after intra-arterial calcium stimulation of the pancreas will be performed.

NCT ID: NCT04706910 Recruiting - Parkinson Disease Clinical Trials

18F-DOPA II - PET Imaging Optimization

Start date: January 20, 2021
Phase: Phase 3
Study type: Interventional

A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism. 2. Pediatric patients (less than 18 years old) with neuroblastoma. 3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor. 4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia. 5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors. Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.

NCT ID: NCT04615546 Recruiting - Clinical trials for Post-Bariatric Hypoglycemia

Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Start date: May 6, 2020
Phase: N/A
Study type: Interventional

Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.

NCT ID: NCT04205604 Recruiting - Clinical trials for Congenital Hyperinsulinism

18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

DOPA PET
Start date: November 3, 2016
Phase: Phase 2
Study type: Interventional

The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.

NCT ID: NCT03930368 Recruiting - Insulinoma Clinical Trials

Application of Raw Corn Starch on Patients With Insulinoma

Start date: April 15, 2019
Phase: N/A
Study type: Interventional

This will be a prospective single-arm before-and-after clinical trial in which raw corn starch (RCS) will be first applied on patients with unoperated insulinoma. Nutritional intervention with supplementation of RCS will be initiated in 20 patients with suspected insulinoma to improve their hypoglycemia before the surgery. Duration of nutritional intervention, fasting blood glucose, lipid profile, weight change, BMI and other metabolic indices will be recorded and compared before and after the intervention.

NCT ID: NCT03768518 Recruiting - Clinical trials for Congenital Hyperinsulinism

GLP-1 Receptor Expression in CHI

GLP-1-CHI
Start date: February 7, 2018
Phase:
Study type: Observational

The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.